TRIGEN INTERTAN CMN Modes of Fixation Trial
Research type
Research Study
Full title
TRIGEN INTERTAN Cephalomedullary Nail Modes of Fixation for Intertrochanteric Fractures: A Prospective Comparative Randomised Trial
IRAS ID
150858
Contact name
Neil Walton
Contact email
Sponsor organisation
Norfolk and Norwich University Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Recent literature suggests that both cephaolomedullary nail (CMN) and sliding or dynamic hip screw (DHS) devices are appropriate for treating unstable intertrochanteric fractures with AO/OTA Classification 32 A2.1-2.3. Our institution currently uses the TRIGEN INTERTAN cephalomedullary nail when surgeon’s preference dictates that CMN fixation would provide improved stability and outcome over DHS. The TRIGEN INTERTAN can be used in three different fixation modes: locked single screw compression, unlocked single screw sliding compression and interlocked linear compression with two screws. The aim of this study is to determine whether the unique “rack and pinion” linear compression mode of fixation results in less post-operative pain, improved functional and radiological outcome and reduced surgical complication rates when compared with the more standard single screw fixation modes.
We propose a prospective, randomized single centre study comparing the use of the TRIGEN INTERTAN nail in single screw fixed, single screw sliding and two interlocked screw conformations. Any patient over the age of 60 presenting with an AO/OTA 32 A2.1, A2.2 or A2.3 non-pathological fracture will be randomised via sealed, opaque and consecutively numbered envelopes at the time of trauma meeting presentation to one of the three conformations. The surgical procedures will be carried out by a number of different consultants and trainees under the supervision of a Smith and Nephew representative. Radiological and clinical follow-up will occur in clinic at 3 and 12 months. Visual Analogue Scores, Harris Hip Scores, EQ-5D, the Up & Go Test and xrays will be used at clinic review to determine outcomes.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
14/EE/1222
Date of REC Opinion
18 Dec 2014
REC opinion
Unfavourable Opinion